1. Field of the Invention
The present invention relates to an apparatus and method for applying and adjusting a sutured anchoring device. More particularly, this invention relates to an apparatus and a method of elevating the urethrovesical junction relative to the bladder to correct female urinary stress incontinence.
2. Description of Related Art
In females, incontinence, or the inability to control the outflow of urine, can have a variety of causes in the urinary system including congenital defects and defects from trauma or disease. The most common cause of female incontinence is known as stress incontinence and results from weakness or relaxation of the urethral sphincter.
Many procedures, several involving urethrovesical elevation, have been devised over the years, to cure urinary stress incontinence. One early procedure involved fixation of the urethrovesical junction to the symphysis pubis by placing sutures through part of the urethral wall, but caused urethral distortion. A modified version of the procedure involved suturing the urethral lumen directly to the symphysis pubis, and placing additional sutures through the bladder. This technique however, often led to urine loss and/or the formation of bladder stones.
An alternative approach involved attaching the urethrovesical junction to the narrow band of strong aponeurotic fibers which extends laterally along the pectineal line of the pubis commonly referred to as Cooper's ligament. In this procedure which is described in U.S. Pat. No. 5,149,329 to Richardson, the urethrovesical junction is elevated by bringing the paravaginal fascia into juxtaposition with Cooper's ligament through suture placement.
A number of procedures for urethrovesical elevation involve anchoring the paravaginal fascia to the abdominal wall. See, for example, U.S. Pat. No. 5,112,344 to Petros which describes looping a filamentary element between the vaginal wall and the rectus abdominis in the anterior wall of the abdomen whereby it passes to each side of the urethra to correct the spacial relationship to the pubis. U.S. Pat. No. 5,019,032 to Robertson describes a method of treatment involving the installation of sutures between the rectus fascia and the vagina by means of a needle inserted through the abdomen.
A sling procedure is disclosed in U.S. Pat. No. 5,013,292 to Lemay and describes a method for correcting female urinary incontinence by implanting a sling-like anchoring device in the skin above the symphysis pubis to adjust the urethrovesical angle. The anchoring device includes a pair of implants each having a head portion adapted to rest on the symphysis pubis and a suture portion connected to the head portion. The head portion is shaped as a figure eight having a central crossbar about which a central portion of the suture is wrapped. Utilizing a bendable needle inserted through the vaginal mucosa, the head portion of each implant is embedded in the skin over the symphysis pubis and the sutures are tied together to support the urethrovesical junction. Alternatively, the ends of the sutures can be tied to a saddle member configured to support the bladder neck.
Such invasive surgical procedures have also been utilized in other areas of the body, including surgery on the gall bladder, appendix, lungs and the like. For the reasons previously stated, the use of laparoscopic and endoscopic surgical procedures have been relatively popular and such popularity has provided additional incentive to develop the procedures further.
In laparoscopic procedures, surgery is performed in the interior of the abdomen through a small incision e.g., through narrow tubes inserted through small entrance wounds in the skin; and in endoscopic procedures, surgery is performed in any hollow viscus of the body. Laparoscopic and endoscopic procedures generally require that any instrumentation inserted into the body be sealed, i.e., provisions must be made to ensure that gases do not enter or exit the body through the laparoscopic or endoscopic incision as, for example, in surgical procedures in which the surgical region is insufflated. Moreover, laparoscopic and endoscopic procedures often require the surgeon to act on organs, tissues and vessels far removed from the incision, thereby requiring that any instruments used in such procedures be long and narrow while being functionally controllable from one end of the instrument, i.e., the proximal end.
Up to the present there remains a need for an apparatus which is particularly adapted to endoscopically apply sutured anchors to body tissue in a manner to positively secure the sutured anchor to the body tissue without the risk of separation. There is also a need in the surgical arts for an improved apparatus to elevate and/or restrain internal organs or structures. In particular, there remains a need to achieve urethrovesical elevation. The present invention relates to such a sutured anchor member, an apparatus for applying the sutured anchor member and a method for attaching and adjusting the sutured anchor member particularly configured and adapted to accomplish these objectives.